Sounding alarm, regulator puts career in danger

BETHESDA, Md. - The first hints of trouble came with vague warnings from the edges of the bureaucracy where she worked.

She was "pushing too hard," being "alarmist."

But it was something else - a clumsy bid to call her off the scent of the dangerous drug she was tracking - that really galled her. "When enough dogs die, this product will take care of itself," a colleague said. Victoria Hampshire's reply tumbled out like a boulder that, once rolling, will no longer stop: "I don't know what I'm doing here then." What Victoria Hampshire was doing - trying to do, at least - was her job: She kept count of side effects from animal drugs for the Food and Drug Administration. She alerted supervisors to potential problems.

And something seemed amiss that spring of 2004.

Wyeth had created what seemed a star performer in Proheart 6, a 3-year-old injected drug to prevent heartworm, the common parasite in dogs. Hampshire's numbers showed, though, that dogs were dying at alarming rates.

What happened next - and the price she paid for speaking up - spurred a U.S. Senate inquiry and shined a spotlight on the complex topography of drug safety, where interests collide like tectonic plates and squeeze decisions from all sides. Hampshire, now age 47, learned compassion for animals growing up on a Virginia horse farm. Her mother raised basset hounds. The daughter - everyone called her Tory - became a champion of humane treatment of animals at the FDA, where her father had been a press officer. Two days after her father's death, Hampshire went toe-to-toe with Wyeth over the deaths of almost 500 dogs that took Proheart 6.

Hampshire and Dr. Linda Tollefson, then deputy head of the FDA's Center for Veterinary Medicine, clearly remember the confrontation at headquarters. As adverse events coordinator, Hampshire was anxious about thousands of reported autoimmune, allergic, liver and other reactions. The deaths surpassed the total for all competitors combined.

But Wyeth's veterinary subsidiary, Fort Dodge Animal Health, had sold 18 million doses of Proheart 6, worth tens of millions of dollars. It surely wouldn't give up without a fight.

The company said Hampshire was inflating her side-effect numbers. Hampshire said Fort Dodge had previously expressed its own concerns over tumors. Fort Dodge said it hadn't.

"Tory did not have experience dealing with animal pharmaceutical community people, who are not different than the human pharmaceutical people. They make a lot of money on this stuff. They will never ever admit there's something wrong," says Tollefson, who is now FDA's assistant commissioner for science. On Sept. 4, 2004, in the face of Hampshire's damning data, Wyeth ordered all Proheart 6 back from vets - without conceding it was dangerous.

It was perhaps the largest recall ever of a pet drug.

Two months later, Wyeth's chief executive officer went to FDA offices for a meeting with then-FDA Commissioner Lester Crawford. The CEO, Robert Essner, wanted to work out a problem: Victoria Hampshire.

His company had uncovered a Web site that gave Hampshire a cut of its drug sales. Though Proheart 6 was sold there, Wyeth focused on competing drugs.

"We felt Dr. Hampshire had a conflict of interest in regard to her evaluation of this product, and we wanted the agency to be aware of it," says Wyeth spokesman Doug Petkus.

Hampshire acknowledges using the Web site, mainly to prescribe drugs for pets of old clients and friends, without needing to warehouse medicines at her Bethesda home. She says she meant to drop the site and hadn't bothered to disclose it as an outside activity that year - a bad decision she now acknowledges. But an invoice shows her earnings were just $160 over 2Â½ years.

Wyeth also accused her of inciting complaints from dog owners. Hampshire says it was her duty to check complaints and help people navigate the FDA.

Wyeth wanted Hampshire reassigned and threatened to sue her, says Tollefson, though Wyeth denies making the demand or threat.

In the end, Crawford "thought it best ... to protect Tory to get her out of it completely," says Tollefson, who was briefed after the top-level meeting. She says she and Sundlof, the center head, agreed to transfer Hampshire.

Tollefson says they also wanted to keep her from being a "distraction" when the recall was reviewed, because they too were troubled by the drug's safety record. Crawford didn't respond to interview requests for this story. In 2005, he abruptly quit the FDA and later admitted hiding stocks he owned in medical and food companies it regulated. He was fined about $90,000. But former FDA lawyer Daniel Troy, also at the Essner-Crawford meeting, defends how it was handled. "At the same time the FDA is actually getting smashed and bashed by the news media on conflicts of interest, here there was an allegation of conflict of interest, and the FDA took it seriously," he says. (AP) Hampshire was working on Proheart 6 data two months later, when she was called in to the veterinary director's office. There, Tollefson waited with an FDA manager of market reviews.

Tollefson inhaled sharply, as if steeling herself. Then she wiped a tear from her eye. "Wyeth has pulled all the plugs at the level of commissioner," Tollefson told a stunned Hampshire. They were transferring her to the vaccines building to care for the rats and monkeys.

She pleaded for her job. They refused to give details but reassured her that this would all blow over. She left the office in tears, angry that she had stinted on time with her sick father to work on Proheart 6. A committee of FDA advisers took up the Proheart 6 recall three weeks later, in January 2005. Hampshire wasn't allowed to talk to them; they voted, 8-7, to keep the drug off the market for the time being. The next month, an agency inspector from Internal Affairs asked to see Hampshire.

A prosecutor had already ruled out most criminal charges over Wyeth's complaint. But the inspector made Hampshire sign a statement saying she could be fired and, if she lied, charged with perjury.

Hampshire dragged herself through the next several months, working at an interm office job. within the capability of "anybody with half a brain," she says. She didn't know where the investigation would lead. She didn't know who might be bent on ruining her career. She fretted at home too. "To take this much stress home and not to sleep for weeks is not worth it," she says. Even her two children noticed her changing. A flicker of light came in April 2005 when she landed a better job in the FDA itself, at an office that evaluates devices for the human heart.

Finally, that July, Hampshire was told she was cleared by agency investigators. "A valued employee" is how FDA spokeswoman Julie Zawisza now describes her, but she won't discuss the transfer and investigation.

Tollefson now believes the affair was mishandled. She says it gave the wrong message: "If you do your job right and you're questioned, you lose your job." Wyeth hopes to be vindicated too. It has approached the FDA with more data for a possible comeback. In June 2005, a Wyeth manager made a sales call at an Alabama veterinary practice, where he blamed Hampshire for the Proheart 6 recall, according to a confidential letter written by a vet there to the FDA. The Wyeth employee said the company had her investigated by private detectives, and she had been "taken care of," according to the letter obtained by The Associated Press. He predicted the drug's swift return to market. That Wyeth manager, Glen Kimmorley, did not answer AP messages left at a home phone in his name. The Wyeth spokesman says Kimmorley "was expressing his own opinion and was not authorized to speak on behalf of the company." However, Sen. Chuck Grassley, R-Iowa, who has been investigating Hampshire's case, says Wyeth "tried to destroy a reputation." He adds: "Her own agency sold her down the river." As she awaits more answers from Senate investigators, she's returned to old routines. Last year, she was at a meeting of the U.S. Public Health Service waiting to hear who'd be named its veterinarian of the year. She grabbed her camera to photograph the winner. And then, as if scripted by Hollywood, her own name was announced. A health officer was saying she had "raised the bar in every category of professional and personal integrity, passion, and commitment." People rushed over to hug her. For the first time in years, she let down her guard.